Examining the role of saturated fat in breast cancer
Gradient-Echo Spectroscopic Imaging Study of Saturated Fat and Breast Cancer
This study is testing whether higher levels of saturated fat in breast tissue can help predict breast cancer in postmenopausal women using a special MRI technique.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 135 (estimated) |
| Ages | 25 Years to 99 Years |
| Sex | Female |
| Sponsor | NYU Langone Health Academic / other |
| Locations | 1 site (New York, New York) |
| Trial ID | NCT03400215 on ClinicalTrials.gov |
What this trial studies
This study aims to investigate the relationship between saturated fatty acids in breast adipose tissue and breast cancer development in postmenopausal women. Using a novel non-invasive MRI technique called Gradient-echo Spectroscopic Imaging (GSI), the study will measure the levels of saturated fat in the breast during routine diagnostic MRI exams. The central hypothesis is that higher levels of saturated fat are associated with malignant lesions and increased inflammation in breast tissue. The findings could enhance current diagnostic methods and inform interventions aimed at reducing cancer-related inflammation.
Who should consider this trial
Good fit: Ideal candidates are postmenopausal women over the age of 25 who are undergoing diagnostic breast MRI exams.
Not a fit: Patients with contraindications to MRI or gadolinium contrast, recent breast surgery, or those on hormonal therapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide new insights into breast cancer risk factors and improve diagnostic accuracy for breast cancer.
How similar studies have performed: While there have been studies on fat's role in breast cancer, this specific approach using GSI is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * No contraindications to MRI scanning (pacemaker, implanted metallic objects, severe obesity or other condition that leads to difficulty lying in the magnet) * No contraindication to gadolinium contrast agent (severe renal insufficiency (EGFR\<30), allergy to gadolinium) which will be injected for clinical exam * Able and willing to provide informed consent * Post-menopausal age \> 25 years. Exclusion Criteria: * Contra-indication to MRI or gadolinium contrast agent (have a pacemaker, aneurysm clip, or other metallic implant; weigh \>135 kg; or have renal impairment) * Breast surgery within prior 12 months, or breast implants * Any hormonal therapy
Where this trial is running
New York, New York
- NYU Langone Health — New York, New York, United States (Recruiting)
Study contacts
- Principal investigator: Linda Moy, MD — NYU Langone Health
- Study coordinator: Reshma Gadde
- Email: Resma.Gadde@nyulangone.org
- Phone: 6465014320
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.